The present invention relates generally to the field of healthcare. Particularly, in the remote monitoring and modulation of a medical device on or in a subject.
Over 100 million people in the United States currently have chronic health conditions and the annual medical costs to treat these patients are rapidly increasing. Consequently, many healthcare providers have initiated outpatient or home healthcare programs for their patients. Unfortunately the success of these programs relies heavily on the ability of the healthcare provider to monitor the patient remotely to avert medical problems before they become complicated and costly.
Initial attempts to remotely monitor patients required the use of interactive telephone or video response systems (U.S. Pat. No. 5,390,238 to Kirk et al., U.S. Pat. No. 5,434,611 to Tamura, and U.S. Pat. No. 5,441,047 to David et al.). The major disadvantage of these systems is the requirement for patient compliance with a rigid monitoring regimen. Often times patients neglect to contact the central facility for monitoring; consequently data collected is sometimes incomplete and inconsistent.
More recent attempts to- monitor patients remotely have included the use of personal computers and the Internet to establish communications between patients and healthcare providers. There are two disadvantages to these methods. First these systems requires that the patient have a computer and be computer literate. Unfortunately not all patients have access to a computer and many may not be computer literate. Second, providing patients with computer systems to assist healthcare providers in monitoring their patients medical condition is cost prohibitive.
Other systems are available that monitor a patients medical condition as well as querying the patients for other information such as quality of life measures or psycho-social variables of their illness. Unfortunately, these systems require extensive patient interaction and compliance with rigid regimens. In addition, the data collected by extensive query are subjective and consequently does not supply the healthcare provider with information on which to adequately instruct the patient. Consequently there is a need for systems and methods that are relatively inexpensive for the patient to purchase and use, and that require minimal patient interaction.
The present invention relates generally to the field of healthcare. Particularly, in the remote monitoring and modulation of a medical device on or in a subject. In some embodiments, the present invention provides a system comprising; a) a medical device capable of detecting subject information; and b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information from the medical device to generate manipulated information. In certain embodiments, the medical device comprises a transmitting and receiving component (e.g. a phone line, cable, antenna, etc). In particular embodiments, the medical device comprises a modem (e.g. for sending and receiving information to and from the internet or world-wide-web). In some embodiments, the medical device comprises computer memory. In preferred embodiments, the medical device comprises a biological fluid measuring device.
In some embodiments, the system of the present invention comprises: a) a medical device capable of detecting subject information; b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information to generate manipulated information; and c) a receiving device comprising computer memory, wherein the receiving device is capable of receiving the subject information from the medical device and transmitting the subject information to the central monitoring system. In certain embodiments, the manipulated information comprises calibration information. In some embodiments, the receiving device is further capable of receiving the manipulated information from the central monitoring system. In further embodiments, the receiving device is further capable of being calibrated by utilizing the manipulated information.
In some embodiments, the central monitoring system comprises computer memory (or a computer memory device), a computer processor, and a data server application. In some embodiments, the computer memory (or computer memory device) and computer processor are part of the same computer. In other embodiments, the computer memory device or computer memory are located on one computer and the computer processor is located on a different computer. In some embodiments, the computer memory is connected to the computer processor through the Internet or World Wide Web. In some embodiments, the computer memory is on a computer readable medium (e.g., floppy disk, hard disk, compact disk, DVD, etc). In other embodiments, the computer memory (or computer memory device) and computer processor are connected via a local network or intranet. In some embodiments, the data server application is stored on the computer memory or computer memory device. In some embodiments, the central monitoring system further comprises computer readable medium with the data server application stored thereon. In further embodiments, the central monitoring system comprises computer memory, a computer processor, and the data server application is located on the computer memory, and the computer processor is able to read the data server application from the computer memory (e.g., ROM or other computer memory) and perform a set of steps according to the data server application (e.g. thereby processing subject information). In certain embodiments, the central monitoring system comprises a computer memory device, a computer processor, a data server application, an interactive device (e.g., keyboard, mouse, voice recognition system), and a display system (e.g., monitor, speaker system, etc.).
In particular embodiments, the receiving device is further capable of displaying the manipulated information. In further embodiments, the receiving device is further capable of transmitting the manipulated information to the medical device. In particular embodiments, the medical device is further capable of being calibrated by utilizing the manipulated information. In some embodiments, the medical device is capable of dispensing an agent in response to the manipulated information (e.g. insulin). In preferred embodiments, the medical device comprises a biological fluid measuring device.
In some embodiments, the system of the present invention comprises: a) a medical device capable of detecting subject information; b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information to generate manipulated information; c) a receiving device comprising computer memory, wherein the receiving device is capable of receiving the subject information from the medical device and transmitting the subject information to the central monitoring system; and d) a hosted electronic environment, wherein the hosted electronic environment is operably linked to the central monitoring system. In some embodiments, the hosted electronic environment comprises a world wide web page. In further embodiments, the world wide web page is interactive (e.g. a subject or physician may manipulate information on the web page). In particular embodiments, the hosted electronic environment is capable of displaying the subject information. In certain embodiments, the hosted electronic environment is capable of displaying the manipulated information. In preferred embodiments, the medical device comprises a biological fluid measuring device.
In some embodiments, the system further comprises a dispensing device, wherein the receiving device is further capable of transmitting the manipulated information to the dispensing device. In particular embodiments, the dispensing device is capable of dispensing an agent in response to the manipulated information.
In certain embodiments, the subject information comprises analyte information (e.g. concentration of a biological agent in biological fluid). In certain embodiments, analyte information comprises the concentration of glucose in blood.
In some embodiments, the system of the present invention comprises: a) a medical device capable of detecting subject information; b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information to generate manipulated information; c) a receiving device comprising computer memory, wherein the receiving device is capable of receiving subject information from the medical device; and d) a docking device comprising computer memory, wherein the docking device is capable of receiving the subject information from the receiving device and transmitting the subject information to the central monitoring system. In certain embodiments, the receiving device is dockable with the docking device. In other embodiments, the system further comprises a calibration device, wherein the calibration device is operably linked to the docking device.
In some embodiments, the system of the present invention comprises: a) a medical device capable of detecting subject information, wherein said medical device comprises a biological fluid measuring device; b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information to generate manipulated information; and c) a receiving device comprising computer memory, wherein the receiving device is capable of receiving the subject information from the medical device and transmitting the subject information to the central monitoring system. In particular embodiments, the biological fluid measuring device comprises; a) a housing comprising electronic circuit means and at least two electrodes operably connected to the electronic circuit means; and b) a sensor means operably connected to the electrodes of the housing, the sensor means comprising; i) a bioprotective membrane, and ii) an angiogenic layer, the angiogenic layer positioned more distal to the housing than the bioprotective membrane.
In some embodiments, the system of the present invention comprises: a) a medical device capable of detecting subject information, wherein said medical device comprises a biological fluid measuring device; b) a central monitoring system comprising computer memory, a computer processor, and a data server application, wherein the central monitoring system is capable of processing the subject information to generate manipulated information; c) a receiving device comprising computer memory, wherein the receiving device is capable of receiving the subject information from the medical device and transmitting the subject information to the central monitoring system; and d) a hosted electronic environment, wherein the hosted electronic environment is operably linked to the central monitoring system. In particular embodiments, the biological fluid measuring device comprises; a) a housing comprising electronic circuit means and at least two electrodes operably connected to the electronic circuit means; and b) a sensor means operably connected to the electrodes of the housing, the sensor means comprising; i) a bioprotective membrane, and ii) an angiogenic layer, the angiogenic layer positioned more distal to the housing than the bioprotective membrane.
In other embodiments, the system of the present invention comprises; a) a medical device, b) a receiving device, and c) a central monitoring system, wherein the medical device obtains information from a subject and provides the information to the receiving device, and wherein the receiving device provides the information to a central monitoring device. In some embodiments, the medical device comprises an implantable medical device. In particular embodiments, the central monitoring system manipulates the information to form manipulated information. In additional embodiments, the central monitoring system provides the manipulated information to the receiving device. In some embodiments, the manipulated information comprises calibration information. In other embodiments, the receiving device modulates the medical device.
In further embodiments, the receiving device is external to a subject. In other embodiments, the system further comprises a docking device. In particular embodiments, the receiving device engages the docking device. In some embodiments, the system further comprises a calibration device. In certain embodiments, the calibration device engages the docking device. In further embodiments, the central monitoring system further comprises a world wide web site. In some embodiments, the world wide web site in interactive. In other embodiments, the medical device monitors an analyte in a subject. In particular embodiments, the analyte is glucose. In some embodiments, the system further comprises a dispensing device that dispenses an agent into a subject. In certain embodiments, the agent is insulin.
In other embodiments, the present invention provides a method of treating a subject comprising; a) providing a system comprising; i) a subject, ii) a medical device, iii) a receiving device, and iv) a central monitoring system, wherein the medical device obtains information from the subject and provides the information to the receiving device, and wherein the receiving device provides the information to a central monitoring device; and b) contacting the subject with the system under conditions such that the medical device obtains information from the subject and provides the information to the receiving device, and wherein the receiving device provides the information to the central monitoring device. In some embodiments, the medical device is implantable. In certain embodiments, the system further comprises a docking device. In particular embodiments, the system further comprises a calibration device. In further embodiments, the system further comprises a dispensing device that dispenses an agent into the subject.
In some embodiments, the present invention provides a method comprising; a) providing; i) a subject, ii) a medical device, iii) a central monitoring system comprising computer memory, a computer processor, and a data server application, and iv) a receiving device comprising computer memory; and b) contacting the medical device with the subject such that the medical device detects subject information; c) receiving the subject information in the receiving device; d) transmitting the subject information to the central monitoring system, and e) processing the subject information with the central monitoring system such that manipulated information is generated. In certain embodiments, the method further comprises a step after step b) of transmitting the subject information to the receiving device. In other embodiments, the method further comprises step f) receiving the manipulated information in the receiving device. In particular embodiments, the method further comprises step g) transmitting the manipulated information to the medical device. In still other embodiments, the manipulated information is utilized by the medical device for calibration. In some embodiments, the manipulated information causes the medical device to dispense an agent. In preferred embodiments, the medical device comprises a biological fluid measuring device.
The devices, systems, and methods of the present invention allow for the implantation of medical devices (e.g. analyte-monitoring devices such as glucose monitoring devices) that result in a dependable flow of blood to deliver sample to the implanted device at a concentration representative of that in the vasculature. Moreover, the medical devices of the present invention become secured within the tissue of the subject, thereby greatly reducing or eliminating the phenomenon of xe2x80x9cmotion artifactxe2x80x9d. In addition, the devices of the present invention utilize materials that eliminate or significantly delay environmental stress cracking at the sensor interface, resulting in the ability to obtain accurate, long-term data.
These effects result, in part, from the use of materials that enhance the formation of a foreign body capsule (FBC). Previously, FBC formation has been viewed as being adverse to sensor function, and researchers have attempted to minimize FBC formation (see, e.g., U.S. Pat. No. 5,380,536 to Hubbell et al.). However, the systems, methods and devices of the present invention utilize specific materials and microarchitecture that elicit a type of FBC that does not hamper the generation of reliable data for long periods. The devices, systems, and methods of the present invention are capable of accurate operation in the approximately 37xc2x0 C., low pO2, environment characteristic of living tissue for extended lengths of time (e.g., months to years).
In some embodiments, the electrode-membrane region of the (medical) devices of the present invention comprises a unique microarchitectural arrangement. In preferred embodiments, the electrode surfaces are in contact with (or operably connected with) a thin electrolyte phase, which in turn is covered by an enzyme membrane that contains an enzyme (e.g., glucose oxidase, and a polymer system). A bioprotective membrane covers this enzyme membrane system and serves, in part, to protect the sensor from external forces and factors that may result in environmental stress cracking. Finally, an angiogenic layer is placed over the bioprotective membrane and serves to promote vascularization in the sensor interface region. It is to be understood that other configurations (e.g., variations of that described above) are contemplated by the present invention and are within the scope thereof.
In some embodiments of the systems and methods of the present invention, the medical device comprises a biological fluid measuring device. In particular embodiments, the biological fluid measuring device comprises; a) a housing comprising electronic circuit means and at least two electrodes operably connected to the electronic circuit means; and b) a sensor means operably connected to the electrodes of the housing, the sensor means comprising; i) a bioprotective membrane, and ii) an angiogenic layer, the angiogenic layer positioned more distal to the housing than the bioprotective membrane. In particular embodiments, the bioprotective membrane is substantially impermeable to macrophages. In some embodiments, the bioprotective membrane comprises pores having diameters ranging from about 0.1 micron to about 1.0 micron. In certain embodiments, the bioprotective membrane comprises polytetrafluoroethylene, and in particular embodiments, the angiogenic layer also comprises polytetrafluoroethylene.
Particular embodiments of the biological fluid measuring device further comprise; c) means for securing the device to biological tissue, the securing means associated with the housing. In some embodiments, the securing means comprises a polyester velour jacket. In preferred embodiments, the securing means covers the top surface (e.g., the top member or the top member sheath, as described further below) and a portion of the sensor interface; it should be noted that the securing means generally should not cover the entire sensor interface, as this would interfere with the ability of blood vessels to deliver sample to the biological fluid measuring device. In preferred embodiments, the securing means comprises poly(ethylene terephthalate).
In further embodiments, the sensor means of the biological fluid measuring device further comprises means for determining the amount of glucose in a biological sample. In some embodiments, the glucose determining means comprises a membrane containing glucose oxidase, the glucose oxidase-containing membrane positioned more proximal to the housing than the bioprotective membrane. In additional embodiments, the housing further comprises means for transmitting data to a location external to the device (e.g., a radiotelemetry device).
The systems and methods of the present invention also contemplate a medical device for measuring glucose in a biological fluid comprising; a) a housing comprising electronic circuit means and at least one electrode operably connected to the electronic circuit means; and b) a sensor means operably connected to the electrode of the housing, the sensor means comprising; i) means for determining the amount of glucose in a biological sample, the glucose determining means operably associated with the electrode, ii) a bioprotective membrane, the bioprotective membrane positioned more distal to the housing than the glucose determining means and substantially impermeable to macrophages, and iii) an angiogenic layer, the angiogenic layer positioned more distal to the housing than the bioprotective membrane.
In particular embodiments, the glucose determining means comprises a membrane containing glucose oxidase. In some embodiments, the angiogenic layer comprises polytetrafluoroethylene.
In some embodiments, the pores of the bioprotective membrane have diameters ranging from about 0.1 micron to about 1.0 micron, while in other embodiments the pores have diameters ranging from about 0.2 micron to about 0.5 micron. In certain embodiments, the bioprotective membrane comprises polytetrafluoroethylene.
Still other embodiments further comprise; c) means for securing the device to biological tissue, the securing means associated with the housing. In particular embodiments, the securing means comprises poly(ethylene terephthalate). Additional embodiments comprise means for transmitting data to a location external to the device; in some embodiments, the data transmitting means comprises a radiotelemetric device.
The present invention also contemplates a method for monitoring glucose levels, comprising a) providing i) a host, and ii) a device comprising a housing and means for determining the amount of glucose in a biological fluid; and b) implanting the device in the host under conditions such that the device measures the glucose accurately for a period exceeding 90 days. In some embodiments, the device measures glucose accurately for a period exceeding 150 days, while in other embodiments, the device measures glucose accurately for a period exceeding 360 days.
The present invention also contemplates a method of measuring glucose in a biological fluid, comprising a) providing i) a host, and ii) a device comprising a housing and means for determining the amount of glucose in a biological fluid, the glucose determining means capable of accurate continuous glucose sensing; and b) implanting the device in the host under conditions such that the continuous glucose sensing begins between approximately day 2 and approximately day 25. In some embodiments, the continuous glucose sensing begins between approximately day 3 and approximately day 21. In particular embodiments, the implanting is subcutaneous.
The devices of the present invention allow continuous information regarding, for example, glucose levels. Such continuous information enables the determination of trends in glucose levels, which can be extremely important in the management of diabetic patients.
In order to facilitate an understanding of the present invention, a number of terms are defined below.
The term xe2x80x9caccuratelyxe2x80x9d means, for example, 95% of measured values within 25% of the actual value as determined by analysis of blood plasma, preferably within 15% of the actual value, and most preferably within 5% of the actual value. It is understood that like any analytical device, calibration, calibration check and recalibration are required for the most accurate operation of the device.
The term xe2x80x9canalytexe2x80x9d refers to a substance or chemical constituent in a biological fluid (e.g., blood or urine) that can be analyzed. The term analyte includes, but is not limited to, lactic acid, ketones, cholesterol, oxygen, drugs, biological enzymes, and glucose. A preferred analyte for measurement by the devices, methods, and systems of the present invention is glucose.
The terms xe2x80x9csensor interface,xe2x80x9d xe2x80x9csensor means,xe2x80x9d and the like refer to the region of a monitoring device (e.g. medical device) responsible for the detection of a particular analyte. For example, in some embodiments of a glucose monitoring device, the sensor interface refers to that region wherein a biological sample (e.g., blood or interstitial fluid) or a portion thereof contacts (directly or after passage through one or more membranes or layers) an enzyme (e.g., glucose oxidase); the reaction of the biological sample (or portion thereof) results in the formation of reaction products that allow a determination of the glucose level in the biological sample. In preferred embodiments of the present invention, the sensor means comprises an angiogenic layer, a bioprotective layer, an enzyme layer, and an electrolyte phase (i.e., a free-flowing liquid phase comprising an electrolyte-containing fluid [described further below]). In some preferred embodiments, the sensor interface protrudes beyond the plane of the housing.
The terms xe2x80x9coperably connected,xe2x80x9d xe2x80x9coperably linked,xe2x80x9d and the like refer to one or more components being linked to another component(s) in a manner that allows transmission of, e.g., signals between the components. For example, one or more electrodes may be used to detect the amount of analyte in a sample and convert that information into a signal; the signal may then be transmitted to electronic circuit means (i.e., the electrode is xe2x80x9coperably linkedxe2x80x9d to the electronic circuit means), which may convert the signal into a numerical value in the form of known standard values.
The term xe2x80x9celectronic circuit meansxe2x80x9d refers to the electronic circuitry components of a biological fluid measuring device required to process information obtained by a sensor means regarding a particular analyte in a biological fluid, thereby providing data regarding the amount of that analyte in the fluid. U.S. Pat. No. 4,757,022 to Shults et al., (hereby incorporated by reference), describes suitable electronic circuit means (see, e.g., FIG. 7); of course, the present invention is not limited to use with the electronic circuit means described therein. A variety of circuits are contemplated, including but not limited to those circuits described in U.S. Pat. Nos. 5,497,772 and 4,787,398, hereby incorporated by reference.
The terms xe2x80x9cangiogenic layer,xe2x80x9d xe2x80x9cangiogenic membrane,xe2x80x9d and the like refer to a region, membrane, etc. of a biological fluid measuring device that promotes and maintains the development of blood vessels microcirculation around the sensor region of the device. As described in detail below, the angiogenic layer of the devices of the present invention may be constructed of membrane materials alone or in combination such as polytetrafluoroethylene, hydrophilic polyvinylidene fluoride, mixed cellulose esters, polyvinyl chloride, and other polymers including, but not limited to, polypropylene, polysulphone, and polymethacrylate.
The phrase xe2x80x9cpositioned more distalxe2x80x9d refers to the spatial relationship between various elements in comparison to a particular point of reference. For example, some embodiments of a biological fluid measuring device comprise both a bioprotective membrane and an angiogenic layer/membrane. If the housing of the biological fluid measuring device is deemed to be the point of reference and the angiogenic layer is positioned more distal to the housing than the bioprotective layer, then the bioprotective layer is closer to the housing than the angiogenic layer.
The terms xe2x80x9cbioprotective membrane,xe2x80x9d xe2x80x9cbioprotective layer,xe2x80x9d and the like refer to a semipermeable membrane comprised of protective biomaterials of a few microns thickness or more which are permeable to oxygen and glucose and are placed over the tip of the sensor to keep the white blood cells (e.g., tissue macrophages) from gaining proximity to and then damaging the enzyme membrane. In some embodiments, the bioprotective membrane has pores (typically from approximately 0.1 to approximately 1.0 micron). In preferred embodiments, a bioprotective membrane comprises polytetrafluoroethylene and contains pores of approximately 0.4 microns in diameter. Pore size is defined as the pore size provided by the manufacturer or supplier.
The phrase xe2x80x9csubstantially impermeable to macrophagesxe2x80x9d means that few, if any, macrophages are able to cross a barrier (e.g., the bioprotective membrane). In preferred embodiments, fewer than 1% of the macrophages that come in contact with the bioprotective membrane are able to cross.
The phrase xe2x80x9cmeans for securing said device to biological tissuexe2x80x9d refers to materials suitable for attaching the devices of the present invention to, e.g., the fibrous tissue of a foreign body capsule. Suitable materials include, but are not limited to, poly(ethylene terephthalate). In preferred embodiments, the top of the housing is covered with the materials in the form of surgical grade fabrics; more preferred embodiments also contain material in the sensor interface region (see FIG. 1B).
The phrase xe2x80x9cmeans for determining the amount of glucose in a biological samplexe2x80x9d refers broadly to any mechanism (e.g., enzymatic or non-enzymatic) by which glucose can be quantitated. For example, some embodiments of the present invention utilize a membrane that contains glucose oxidase that catalyzes the conversion of glucose to gluconate: Glucose+O2xe2x86x92Gluconate+H2O2. Because for each glucose molecule converted to gluconate, there is a proportional change in the co-reactant O2 and the product H2O2, one can monitor the current change in either the co-reactant or the product to determine glucose concentration.
The phrase xe2x80x9cmeans for transmitting data to a location external to said devicexe2x80x9d refers broadly to any mechanism by which data collected by a biological fluid measuring device implanted within a subject may be transferred to a location external to the subject. In preferred embodiments of the present invention, radiotelemetry is used to provide data regarding blood glucose levels, trends, and the like.
The terms xe2x80x9cradiotelemetry,xe2x80x9d xe2x80x9cradiotelemetric device,xe2x80x9d and the like (e.g. telemetry) refer to the transmission by radio waves of the data recorded by the implanted device to an ex vivo recording station (e.g., a computer), or transmission of radio waves of information by other devices (e.g. receiving device, central monitoring system) to another device, where the data is recorded and, if desired, further processed (see, e.g., U.S. Pat. Nos. 5,321,414 and 4,823,808, hereby incorporated by reference; PCT Patent Publication WO 9422367).
The phrase xe2x80x9ccontinuous glucose sensingxe2x80x9d refers to the period in which monitoring of plasma glucose concentration is continuously carried out. More specifically, at the beginning of the period in which continuous glucose sensing is effected, the background sensor output noise disappears, and the sensor output stabilizes (e.g., over several days) to a long-term level reflecting adequate microcirculatory delivery of glucose and oxygen to the tip of the sensor (see FIG. 2). Though an understanding of this effect is not required in order to practice the present invention, it is believed to be due to adequately vascularized foreign body capsule tissue in consistent contact with the sensor interface of the blood glucose monitoring device. Failure of adequate vascularization or consistent contact of tissue with sensor will result in failure of continuous glucose sensing.
As used herein, the term xe2x80x9csubjectxe2x80x9d or xe2x80x9chostxe2x80x9d refers to animals, and includes, but is not limited to, humans, cats, dogs, pigs, cows, sheep, and the like.
As used herein, the term xe2x80x9cmedical devicexe2x80x9d refers to any instrument or apparatus that may be contacted externally to or implanted in a subject. In some embodiments, the medical device is capable of obtaining information concerning a medical condition or biological condition or medical treatment of a subject, and is also capable of transmitting the information (e.g. information is transmitted periodically by telemetry). In preferred embodiments, the medical device comprises a biological fluid measuring device.
As used herein, the term xe2x80x9creceiving devicexe2x80x9d refers to any device that is able to receive, and store information. For example, a receiving device may be capable of receiving information from a medical device, central monitoring system, a docking device, or other source. In some embodiments, the receiving device is further capable of transmitting information (e.g. subject information or manipulated information). In some embodiments, the information is received from the medical device periodically with time, date and identification codes and is preferably by telemetry. In other embodiments, the information (e.g. manipulated information) is transmitted to the medical device by telemetry.
As used herein, the term xe2x80x9ccentral monitoring systemxe2x80x9d refers to any device or collection of devices comprising computer memory, a computer processor, and a data server application, that is capable or receiving and transmitting information (e.g. subject information and/or manipulated information). In preferred embodiments, the central monitoring system is capable of sending and receiving information via the internet or world-wide-web. In particularly preferred embodiments, the central monitoring system is capable of processing information.
As used herein, term xe2x80x9cdata server applicationxe2x80x9d refers to any software program that is capable of processing information (e.g. subjection information). An example includes, but is not limited to, a data server application from BEA.com that is customized by software engineers to include glucose data, calibration information, time stamps, and unique ID codes.
As used herein, the term xe2x80x9cdocking devicexe2x80x9d refers to any device that is able to receive and transmit information obtained from a receiving device or a central monitoring system, and is also capable of physical connection to a receiving device.
As used herein, the term xe2x80x9ccalibration devicexe2x80x9d refers to any device that is capable of being employed to obtain independent information on a subject""s medical condition. For example, the calibration device may be a device used (or capable of being used) by a subject to obtain an independent analyte concentration from a biological sample.
As used herein, the term xe2x80x9cagentxe2x80x9d refers to any substance or chemical that may be dispensed (e.g. into a subject from a medical device or dispensing device). The type of agent dispensed will depend on the condition being treated by detection of a particular analyte that is an indicator of that condition. For example, if the medical condition being monitored is diabetes the preferred analyte to detect is glucose and the preferred agent is insulin, if the medical condition being monitored is hypoglycemia the preferred analyte to detect is glucose and the preferred agent is glucagon, if the medical condition being monitored is thrombosis the preferred analyte is prothrombin and the preferred agent may be heparin.
As used herein, the term xe2x80x9cmodulationxe2x80x9d refers to any modification of information, a medical device or receiving device. Modulation of information (e.g. subject information) may be, for example, by modification or by interpretation of the information. For example, modulation of information may be providing a new or modified concentration calibration factor that is utilized by a device to provide an accurate analyte concentration value for transmission.
As used herein, the term xe2x80x9cmanipulated informationxe2x80x9d refers to information that have been modified or changed. For example, subject information that has been processed by a data server application is manipulated information.
As used herein, the term xe2x80x9csubject informationxe2x80x9d refers to data collected on a subject in regard to physiological condition (e.g. glucose concentration in the blood).
As used herein, the term xe2x80x9cInternetxe2x80x9d refers to a collection of interconnected (public and/or private) networks that are linked together by a set of standard protocols (such as TCP/IP and HTTP) to form a global, distributed network. While this term is intended to refer to what is now commonly known as the Internet, it is also intended to encompass variations which may be made in the future, including changes and additions to existing standard protocols.
As used herein, the terms xe2x80x9cWorld Wide Webxe2x80x9d or xe2x80x9cWebxe2x80x9d refer generally to both (i) a distributed collection of interlinked, user viewable hypertext documents (commonly referred to as Web documents or Web pages) that are accessible via the Internet, and (ii) the client and server software components which provide user access to such documents using standardized Internet protocols. Currently, the primary standard protocol for allowing applications to locate and acquire Web documents is HTTP, and the Web pages are encoded using HTML. However, the terms xe2x80x9cWebxe2x80x9d and xe2x80x9cWorld Wide Webxe2x80x9d are intended to encompass future markup languages and transport protocols which may be used in place of (or in addition to) HTML and HTTP.
As used herein, the term xe2x80x9cWeb Sitexe2x80x9d refers to a computer system that serves informational content over a network using the standard protocols of the World Wide Web. Typically, a Web site corresponds to a particular Internet domain name, and includes the content associated with a particular organization. As used herein, the term is generally intended to encompass both (i) the hardware/software server components that serve the informational content over the network, and (ii) the xe2x80x9cback endxe2x80x9d hardware/software components, including any non-standard or specialized components, that interact with the server components to perform services for Web site users.
As used herein, the term xe2x80x9cclient-serverxe2x80x9d refers to a model of interaction in a distributed system in which a program at one site sends a request to a program at another site and waits for a response. The requesting program is called the xe2x80x9cclient,xe2x80x9d and the program which responds to the request is called the xe2x80x9cserver.xe2x80x9d In the context of the World Wide Web, the client is a xe2x80x9cWeb browserxe2x80x9d (or simply xe2x80x9cbrowserxe2x80x9d) which runs on a computer of a user; the program which responds to browser requests by serving Web pages is commonly referred to as a xe2x80x9cWeb server.xe2x80x9d
As used herein, the term xe2x80x9cHTMLxe2x80x9d refers to HyperText Markup Language which is a standard coding convention and set of codes for attaching presentation and linking attributes to informational content within documents. During a document authoring stage, the HTML codes (referred to as xe2x80x9ctagsxe2x80x9d) are embedded within the informational content of the document. When the Web document (or HTML document) is subsequently transferred from a Web server to a browser, the codes are interpreted by the browser and used to parse and display the document. Additionally in specifying how the Web browser is to display the document, HTML tags can be used to create links to other Web documents (commonly referred to as xe2x80x9chyperlinksxe2x80x9d).
As used herein, the term xe2x80x9cHTTPxe2x80x9d refers to HyperText Transport Protocol which is the standard World Wide Web client-server protocol used for the exchange of information (such as HTML documents, and client requests for such documents) between a browser and a Web server. HTTP includes a number of different types of messages which can be sent from the client to the server to request different types of server actions. For example, a xe2x80x9cGETxe2x80x9d message, which has the format GET, causes the server to return the document or file located at the specified URL.
As used herein, the term xe2x80x9cURLxe2x80x9d refers to Uniform Resource Locator which is a unique address which fully specifies the location of a file or other resource on the Internet. The general format of a URL is protocol://machine address:port/path/filename. The port specification is optional, and if none is entered by the user, the browser defaults to the standard port for whatever service is specified as the protocol. For example, if HTTP is specified as the protocol, the browser will use the HTTP default port of 80.
As used herein, the terms xe2x80x9ccomputer memoryxe2x80x9d and xe2x80x9ccomputer memory devicexe2x80x9d refer to any storage media readable by a computer processor. Examples of computer memory include, but are not limited to, RAM, ROM, computer chips, digital video disc (DVDs), compact discs (CDs), hard disk drives (HDD), and magnetic tape.
As used herein, the term xe2x80x9ccomputer readable mediumxe2x80x9d refers to any device or system for storing and providing information (e.g., data and instructions) to a computer processor. Examples of computer readable media include, but are not limited to, DVDs, CDs, hard disk drives, magnetic tape and servers for streaming media over networks.
As used herein, the terms xe2x80x9ccomputer processorxe2x80x9d and xe2x80x9ccentral processing unitxe2x80x9d or xe2x80x9cCPUxe2x80x9d are used interchangeably and refers to a device that is able to read a program from a computer memory (e.g., ROM or other computer memory) and perform a set of steps according to the program.
As used herein, the term xe2x80x9chosted electronic environmentxe2x80x9d refers to an electronic communication network accessible by computer for transferring information. One example includes, but is not limited to, a web site located on the world wide web.